| Title |
PRESBIA: Manager, Regulatory Affairs |
| Description |
Position Purpose:
The Regulatory Affairs Manager will ensure compliance with existing, new and/or revised regulatory requirements applicable to Presbia. The candidate must have a solid foundation in regulatory affairs and working knowledge of medical device regulations. This includes both domestic and foreign regulatory standards as well as preparing and filing required reports. This is a hands-on position that requires the ability to work independently and autonomously.
Job Responsibilities:
• Manage the preparation, documentation and submission of FDA applications for Class I, II and III medical devices (e.g. PMAs, supplements, 510K)
• Work with senior management to develop and implement regulatory strategies for U.S., EU and OUS submissions
• Review labeling and promotional material
• Assist with post-market compliance
• Write, review and submit submission packages to global health agencies to gain product approvals (e.g., Design Dossier, etc.)
• Communicate and negotiate with global health agencies
• Review all regulatory agency compliance materials to guarantee accuracy, timeliness, comprehensiveness, and obedience with regulatory standards.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Create or implement regulatory affairs rules and procedures to make sure that regulatory compliance is sustained or enhanced.
• Have in depth knowledge in Quality Systems and Good Manufacturing Practices in order to assure company compliance.
• Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
• Provide responses to regulatory agencies regarding product information or issues.
• Maintain current knowledge of relevant regulations including proposed and final rules.
• Maintain database of FDA-approved and marketing approved medical devices.
• Respond to complaints and queries on FDA-related and other regulatory related issues.
• Support external audits from regulatory agencies.
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